MedDataX Logo

A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder

NCT ID: NCT04007367

Last Updated: 2023-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-06

Study Completion Date

2020-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder (MDD).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open-Label Phase: SAGE-217

Participants self-administered SAGE-217, 30 milligrams (mg), oral capsule, once daily (QD) in the evening from Day 1 to Day 14.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 capsule

Double-Blind Phase: Placebo

Following the OL Phase, participants who exhibited a Hamilton Rating Scale for Depression (HAM-D) response, defined as a greater than or equal to (≥) 50% reduction from baseline in HAM-D total score were to be randomized to receive SAGE-217 matching placebo capsule, orally, QD, in the evening, in a total of five, 14-day treatment periods, each separated by a 6-week follow-up period during the 40-week DB Phase of the study. However, no participants were randomized to receive SAGE-217 matching placebo due to early study termination.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SAGE-217 matching placebo capsule

Double-Blind Phase: SAGE-217

Following the OL Phase, participants who exhibited a HAM-D response defined as a ≥ 50% reduction from baseline in HAM-D total score to SAGE-217 were randomized to receive SAGE-217, 30 mg, oral capsule, QD, in the evening, up to study termination date (i.e., up to approximately 22 weeks) during the DB Phase of the study.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SAGE-217

SAGE-217 capsule

Intervention Type DRUG

Placebo

SAGE-217 matching placebo capsule

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participant had a diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been present for at least a 4-week period.
2. Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
3. Participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia \[CBT-I\]) until after study completion.

Exclusion Criteria

1. Participant had attempted suicide associated with the current episode of MDD.
2. Participant had treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) was used for this purpose.
3. Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sage Investigational Site

Bentonville, Arkansas, United States

Site Status

Sage Investigational Site

Bellflower, California, United States

Site Status

Sage Investigational Site

Garden Grove, California, United States

Site Status

Sage Investigational Site

Lemon Grove, California, United States

Site Status

Sage Investigational Site

Oceanside, California, United States

Site Status

Sage Investigational Site

Orange, California, United States

Site Status

Sage Investigational Site

Riverside, California, United States

Site Status

Sage Investigational Site

San Diego, California, United States

Site Status

Sage Investigational Site

San Marcos, California, United States

Site Status

Sage Investigational Site

Sherman Oaks, California, United States

Site Status

Sage Investigational Site

Coral Springs, Florida, United States

Site Status

Sage Investigational Site

Jacksonville, Florida, United States

Site Status

Sage Investigational Site

Lauderhill, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

Sage Investigational Site

Alpharetta, Georgia, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Decatur, Georgia, United States

Site Status

Sage Investigational Site

Chicago, Illinois, United States

Site Status

Sage Investigational Site

Lincolnwood, Illinois, United States

Site Status

Sage Investigational Site

Lake Charles, Louisiana, United States

Site Status

Sage Investigational Site

Gaithersburg, Maryland, United States

Site Status

Sage Investigational Site

Boston, Massachusetts, United States

Site Status

Sage Investigational Site

Methuen, Massachusetts, United States

Site Status

Sage Investigational Site

Watertown, Massachusetts, United States

Site Status

Sage Investigational Site

Ann Arbor, Michigan, United States

Site Status

Sage Investigational Site

Las Vegas, Nevada, United States

Site Status

Sage Investigational Site

Berlin, New Jersey, United States

Site Status

Sage Investigational Site

Cherry Hill, New Jersey, United States

Site Status

Sage Investigational Site

Marlton, New Jersey, United States

Site Status

Sage Investigational Site

Albuquerque, New Mexico, United States

Site Status

Sage Investigational Site

Jamaica, New York, United States

Site Status

Sage Investigational Site

New York, New York, United States

Site Status

Sage Investigational Site

New York, New York, United States

Site Status

Sage Investigational Site

Rochester, New York, United States

Site Status

Sage Investigational Site

Dayton, Ohio, United States

Site Status

Sage Investigational Site

North Canton, Ohio, United States

Site Status

Sage Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Sage Investigational Site

Allentown, Pennsylvania, United States

Site Status

Sage Investigational Site

Memphis, Tennessee, United States

Site Status

Sage Investigational Site

Austin, Texas, United States

Site Status

Sage Investigational Site

Dallas, Texas, United States

Site Status

Sage Investigational Site

Richardson, Texas, United States

Site Status

Sage Investigational Site

Wichita Falls, Texas, United States

Site Status

Sage Investigational Site

Everett, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-002640-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

217-MDD-302

Identifier Type: -

Identifier Source: org_study_id